Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Silver Diamine Fluoride
- Conditions
- Dental Caries in Children
- Sponsor
- Cairo University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Discoloration
- Last Updated
- 7 years ago
Overview
Brief Summary
To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.
Detailed Description
The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation. Benefit to the patient * No pain and infection. * Enhance child cooperation. * Enhance better patient compliance. * Decrease cost of dental treatment and may eliminate the need for General Anesthesia. Benefit to the dentist * Develop an effective fast easy method to arrest the caries by using SDF. * Ease of dental treatment. * Better cooperation with the child. * The procedure is simple. * Inexpensive and non-invasive. * It does not require expensive equipment or support infrastructure, such as pipe water or electricity. Benefit to the population * Reduce the harmful impact of oral health problems in preschool children from low income families. * SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities. Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.
Investigators
Yousra Mohamed
Principal investigator
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Children with carious primary teeth before eruption of permanent teeth
- •High caries risk patients with anterior or posterior carious lesions
- •Uncooperative children without access to or with difficulty accessing dental care.
Exclusion Criteria
- •Children with spontaneous or elicited pain from caries
- •Tooth mobility
- •Signs of pulpal infection
- •Severe medical conditions that would not allow management in the clinic
Arms & Interventions
Group 1
38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid
Intervention: Silver Diamine Fluoride
Group 2
5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12
Intervention: Sodium Fluoride Varnish
Outcomes
Primary Outcomes
Discoloration
Time Frame: 12 months
Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
Secondary Outcomes
- Timing of discoloration(12 months)
- Postoperative Pain: Questioning the patient(12 months)
- Investigator reported discoloration(12 months)
- Caries arrest (dentine texture)(12 months)
- Parental satisfaction: Questioning the parent(12 months)